Robotic-assisted versus open partial nephrectomy: A prospective multicenter comparison study of perioperative outcomes (AGILE project)

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Minervini A.1_{, Vittori G.}1_{, Antonelli A.}2_{, Celia A.}3_{, Crivellaro S.}4_{, Dente D.}5_{, Di Santo V.}5_{, Frea B.}4_{, Gacci M.}1_{, Gritti A.}2_{, Masieri L.}1_{, Morlacco A.}4_{, Porreca} A.5_{, Rocco B.}6_{, Parma P.}7_{, Serni S.}1_{, Simeone C.}2_{, Zaramella S.}8_{, Carini M.}1

1_{University of Florence, Dept. of Urology, Florence, Italy,}2_{University of Brescia, Dept. of Urology, Brescia, Italy,}3_{Hospital of Bassano Del Grappa, Dept. of} Urology, Bassano del Grappa, Italy, 4University of Udine, Dept. of Urology, Udine, Italy, 5Hospital of Abano Terme, Dept. of Urology, Abano Terme, Italy, 6_{University of Milan, Dept. of Urology, Milan, Italy,}7_{Hospital Carlo Poma, Dept. of Urology, Mantova, Italy,}8_{Hospital “Maggiore Della Carità”, Dept. of} Urology, Novara, Italy

INTRODUCTION & OBJECTIVES: To compare perioperative outcomes of open partial nephrectomy (OPN) with those of robotic assisted partial nephrectomy (RAPN), in a prospective multicenter dataset.

MATERIAL & METHODS: The AGILE project is a 2-Year prospective observational study that includes patients treated with OPN or RAPN between 2010 and 2011 at six Italian urologic centers. All clinical variables including tumor nephrometry (PADUA score) and laboratory analyses were recorded. Surgical results and complications, stratified with Clavien system, and pathological data were registered. All significant differences in OPN versus RAPN group were assessed. Independent predictors of surgical complications were evaluated with multivariate analysis.

RESULTS: 198 and 104 patients were enrolled in the OPN and RAPN group, respectively. As summarized in the table, Charlson comorbility index was significantly higher in RAPN group while clinical tumor diameter and imperative surgical indication were higher in OPN group.

Pedicle clamping was used in 48% and 62,5% of OPN and RAPN group, respectively. In RAPN group 1 procedure was converted to open due to vascular lesion. At univariate analysis, there was no significant difference in warm ischemia time, intraoperative complications, postoperative medical complications, delta of serum creatinine, positive surgical margin and benign tumor rates. The operative time resulted significantly higher in RAPN group, while the estimated blood loss, the delta of serum Hemoglobin and the postoperative surgical complications were significantly higher in OPN group. 9,6% of Clavien grade 3-4 surgical complications occurred in OPN group, while 1 in RAPN group (p=0,001). Ureteral stenting for urinary fistula was needed in 4% and 0% in the OPN and RAPN group, respectively (p=0,008). Revision of postoperative bleeding was needed in 2,5% and 1% (p=0,07). At multivariate analysis, the imperative indication and the surgical approach (Open vs Robotic) resulted independently correlated with postoperative surgical complications (RR=3,8; p=0,05 and RR=4,2; p=0,01,respectively).

259 Robotic-assisted versus open partial nephrectomy: A prospective multicenter comparison study of

perioperative outcomes (AGILE project)

Eur Urol Suppl 2013;12;e259

Partial nephrectomy OPN RAPN P

N patients 198 104 Ns Male gender 62% 65.4% Ns Age (years) 63,8 ± 12,4 63 ± 11 Ns BMI 27,2 ± 4,9 26,1 ± 4 Ns ASA score 3 14,6% 14% Ns Charlson Index ≥ 2 5,6% 26% 0,04 Imperative indications 5,05% 1% 0,07

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CONCLUSIONS: In our analysis the robotic approach clearly improved the incidence of postoperative complication and the reintervention rate. Further studies are needed to evaluate surgical, functional and oncological results of RAPN.

Clinical tumor diameter 3,5 ± 1,8 2,8 ± 1,5 cm 0,0002

PADUA score ≥ 10 7,1% 6.3% Ns

Reduction of Hb (g/dL) 3,1 ± 1,9 2,3 ± 1,5 0,0019

Increase of serum creatinine (mg/dL) 0,2 ± 0,3 0,3 ± 0,1 Ns

WIT (min) 18,7 ± 8,1 18,2 ± 7 Ns

Operative time (min) 123 ± 43 168 ± 56 <0,0001

EBL (mL) 230 ± 208 115 ± 107 0,0004

Intraoperative complications (%) 5,1% 2.9% Ns

Conversion to open - 1/104 1% Ns

Overall postoperative complications _{48/198 24,2%} 9/104 8,7% _Ns

SURGICAL postoperative complications 42/198 21,2% 6/104 5,8% <0,0001

MEDICAL postoperative complications 3,0% 2,9% Ns

Clavien 3-4 surgical complications 19/198 9,6% 0 0,001

Urinary fistula with ureteral stent 8/198 4,0% 0 Ns

Clavien 3-4 postoperative bleeding 5/198 2,5% 1/104 1% 0,07

Benign tumors 21,2% 13,5% Ns

pT3a (invasion of perirenal fat) 6,0% 9,6% Ns